KARL STORZ AUTOFLURESCENCE SYSTEM
FDA premarket approval P020008/S001 · decided 2005-03-04
Approval details
- PMA number
- P020008
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KARL STORZ AUTOFLURESCENCE SYSTEM
- Generic name
- SYSTEM, IMAGING, FLUORESCENCE
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2005-02-07
- Decision date
- 2005-03-04
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MRK
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Culver City, CA
- Statement
- CHANGE IN THE OEM SENSOR FOR THE KARL STORZ AUTOFLUORESCENCE SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.